Another omega-3 fatty acid formulation—omega-3 carboxylic acids—has been approved by the Food and Drug Administration for treating adults with severe hypertriglyceridemia, the manufacturer, AstraZeneca, announced.
The product will be available in 1-g capsules, the recommended dosages are 2 g or 4 g per day, and it will be marketed as Epanova, the statement said.
The prescribing information describes Epanova as "a fish oil–derived mixture of free fatty acids primarily composed of EPA [eicosapentaenoic acid] and DHA [docosahexaenoic acid]." The approved indication is as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglycerides of 500 mg/dL or greater).
Approval was based on the results of EVOLVE (Epanova for Lowering Very High Triglycerides), a phase III study that evaluated the effects of Epanova on triglycerides and other lipids in patients with very high triglyceride levels, according to the company.
"The effect of EPANOVA on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined," the statement said.
AstraZeneca is pursuing approval of Epanova as a treatment for severe hypertriglyceridemia in other countries, and is planning to develop a fixed-dose combination of Epanova with a statin.
The safety and efficacy of Epanova plus statin therapy will be evaluated in the STRENGTH (Statin Residual Risk Reduction With Epanova in High Cardiovascular Risk Patients With Hypertriglyceridemia) trial, a large cardiovascular outcomes study of patients with mixed dyslipidemia who are at an increased risk of cardiovascular disease, according to the company.
The study is a randomized, double-blind, controlled trial that will compare a corn oil capsule plus a statin or Epanova plus a statin, once a day for about 3-5 years in about 13,000 patients, according to the clinicaltrials.gov website. The primary outcome will be the time to the first occurrence of any component of the composite of major adverse cardiac events (cardiovascular death, nonfatal MI, nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina).
At a meeting in October 2013, the majority of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended waiting for the results of an ongoing cardiovascular outcomes trial before expanding the approval of another omega-3 fatty acid, icosapent ethyl plus a statin, for reducing triglycerides in adults with mixed dyslipidemia who are at a high risk of coronary heart disease. Panelists said the results of that study (REDUCE-IT) were needed before this indication was approved to determine if the beneficial effects of the combined treatment on lipids translated into improved cardiovascular outcomes. Icosapent ethyl, marketed as Vascepa, was approved in 2012 as a treatment for severe hypertriglyceridemia.
The Epanova prescribing information is available here.